FDA 510(k) Application Details - K250455

Device Classification Name	More FDA Info for this Device
510(K) Number	K250455
Device Name	FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
Applicant	FLUOPTICS SAS (a Getinge Group Company} 44 rue des berges Grenoble 38000 FR Other 510(k) Applications for this Company
Contact	Marion Boudet Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2025
Decision Date	04/17/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review